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Effect of Alum Stone Containing Mucosal Adhesive Patches on Healing of Recurrent Aphthous Stomatitis

Effect of Alum Stone Containing Mucosal Adhesive Patches on Healing of Recurrent Aphthous Stomatitis: A Randomized Double-blinded Placebo-controlled Clinical Trial

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06960278
Enrollment
100
Registered
2025-05-07
Start date
2021-02-05
Completion date
2023-03-02
Last updated
2025-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aphthous Stomatitis, Aphthous Stomatitis, Recurrent, Aphthous Ulcer

Keywords

Alum stone, aphthous ulcer, mucosal adhesive patches

Brief summary

The evaluation of recurrent aphthous stomatitis (RAS) was performed by an oral medicine specialist, who relied on the clinical manifestations of the condition. The experimental group was administered 1x1cm mucosal patches containing alum stone at a concentration of 7%, whereas the control group was given placebo patches without any active medication. Size of aphthous lesions and degree of pain assessed at days 1, 3, and 5. Statistical analysis was performed with repeated measures ANOVA using R software.

Detailed description

The study's results indicated that the utilization of alum stone in mucosal adhesive patches yielded significant reductions in size of aphthous lesions and degree of pain.

Interventions

PROCEDURESize of aphthous lesions and degree of pain assessed at days 1, 3, and 5.

Size of aphthous lesions and degree of pain assessed at days 1, 3, and 5.

PROCEDUREControl

The dimensions of the lesion were measured by oral medicine specialists using a flexible ruler

DEVICEALUMSTONE

alum administration via adhesive patches on the healing process of aphthous ulcers

Sponsors

University Of Anbar
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Intervention model description

In this study one hundred female, aged between twenty-two and thirty years, reported multiple oral aphthous ulcers. The evaluation of recurrent aphthous stomatitis (RAS) was performed by an oral medicine specialist, who relied on the clinical manifestations of the condition. The experimental group was administered 1x1cm mucosal patches containing alum stone at a concentration of 7%, whereas the control group was given placebo patches without any active medication. Size of aphthous lesions and degree of pain assessed at days 1, 3, and 5. Statistical analysis was performed with repeated measures ANOVA using R software

Eligibility

Sex/Gender
FEMALE
Age
22 Years to 35 Years
Healthy volunteers
Yes

Inclusion criteria

individuals who had a history of RAS, with oral ulceration occurring at least once a month and persistent oral ulceration being present in the majority of patients. Additionally, individuals with mild aphthous ulcer, characterized by ulcer development lasting fewer than three days, were also included. \-

Design outcomes

Primary

MeasureTime frame
Lesion Size1, 3, 5 day

Countries

Iraq

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026